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pegvisomant

Phase 4FDA approved

Acromegaly | Small molecule | Endocrine |Pfizer, Inc.|Trials Updated: Jul 29, 2008

pegvisomant development status

FDA approval on record Mar 25, 2003 as Somavert
Approval holderPharmacia
ApplicationBLA021106
Highest phase Phase 4 (NCT00068029)
Phase scored for PFEPhase 3
Registered trials 8 across 4 sponsors since Sep 2003

Label indication SOMAVERT is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum insulin-like growth factor-1 (IGF-1) levels. FDA label

pegvisomant target and mechanism

Molecular targetGHR
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

pegvisomant clinical trials

pegvisomant · 1 trial · 1 indication

Phase 3 1
NCT00143416Long Term Study With B2036-PEGAcromegaly
COMPLETED16 Analytics
PHASE3COMPLETED
Long Term Study With B2036-PEG
AcromegalyUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the safety and efficacy of long-term B2036-PEG therapy in patients with acromegaly

Secondary Endpoints

PK/PD evaluation
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
PegvisomantDRUG -
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Eligibility Criteria

Age Range20 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Patients with acromegaly who have received at least one dose of B2036-PEG in the preceding study (A6291009). Exclusion Criteria: * Switching to other therapeutic methods for acromegaly

Countries:Japan
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Frequently asked questions about pegvisomant

What is pegvisomant used for?

Pegvisomant is used for the treatment of acromegaly, a hormonal disorder in which the pituitary gland produces excess growth hormone. It is an endocrine therapy developed by Pfizer, Inc. (ticker PFE) and is given to patients with this condition.

What does pegvisomant target?

Pegvisomant targets the growth hormone receptor, or GHR. It acts as a receptor antagonist, meaning it blocks the growth hormone receptor rather than activating it. By binding to GHR and blocking signaling, pegvisomant reduces the effects of excess growth hormone in patients with acromegaly.

Who makes pegvisomant?

Pegvisomant is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the company associated with the clinical development of this acromegaly therapy.

What phase is pegvisomant in?

Pegvisomant is in Phase 3 clinical development for acromegaly. It is an investigational therapy in this development program, and the Phase 3 trial listed for it has been completed.

What clinical trials is pegvisomant in?

Pegvisomant has been studied in the Phase 3 trial NCT00143416, titled Long Term Study With B2036-PEG. That trial enrolled 16 participants with acromegaly in Japan and is completed. It was an uncontrolled study without randomization or double blinding.

Is pegvisomant FDA approved?

Pegvisomant is an investigational therapy in Phase 3 clinical development for acromegaly. The available development information describes a completed Phase 3 trial rather than an approved product, so pegvisomant should be regarded as still in clinical development.